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Table of Contents
ORIGINAL ARTICLES
Year : 2019  |  Volume : 7  |  Issue : 3  |  Page : 151-162

Comparative therapeutic response of instant and incremental oleation (Sadya and Aarohi Snehapana) over hematological and biochemical parameters in healthy volunteers: A pilot study


1 Department of Panchakarma, Mahatma Gandhi Ayurved College, Hospital and Research Centre, DMIMS (DU), Wardha, Maharashtra, India
2 Department of Rachana Sharir, Mahatma Gandhi Ayurved College, Hospital and Research Centre, DMIMS (DU), Wardha, Maharashtra, India

Date of Submission25-Dec-2019
Date of Decision02-Jan-2020
Date of Acceptance06-Jan-2020
Date of Web Publication31-Jan-2020

Correspondence Address:
Dr. Gaurav R Sawarkar
Department of Rachana Sharir, Mahatma Gandhi Ayurved College, Hospital and Research Centre, DMIMS (DU), Salod (Hirapur), Wardha 442001, Maharashtra.
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/JISM.JISM_66_19

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  Abstract 

Introduction: Snehapana (oleation) is the prerequisite treatment for the purification in Panchakarma. Internal oleation therapy is essential for the Dosha migration in the body. So, to identify the effectiveness of instant oleation with incremental as well as safety nature of intervention, the pilot study was planned. Materials and Methods: The study was randomized, parallel group, controlled trial. Participants eligible for internal oleation were included in the study, having age in-between 20 and 40 years. Plane cow ghee was the intervention for both groups. The only difference was in dose pattern. In Group A, 150mL cow ghee with rock salt as used instant administration, whereas in Group B, administration was carried out in incremental dose from 30mL to maximum 210mL (up to the appearance of proper oleation features). Fifteen participants were recruited in each group. Randomization was carried out with simple block method. Objective: The pilot study was intended to measure the hematological and biochemical changes appearing after Snehapana (internal oleation). Outcome: The primary trial objectives of the study were to evaluate therapeutic response of internal oleation in instant and incremental manner and to find out effective modality in vogue. Secondary outcome was to assess safety for the consumption of cow ghee in large amount, which is not good as pretended by contemporary science. Conclusion: Intended primary outcome was not possible to attain because of small sample size. But significant results were obtained in some parameters such as blood urea, serum bilirubin, total bilirubin, serum triglyceride, serum glutamic-pyruvic transaminase, and very low-density lipoprotein (P < 0.05) but within normal range, and the intervention in both were safe in nature, none of the participants had developed any harm in the study. Further clinical trial is suggested for large sample size.

Keywords: Biochemical, hematological, oleation, Sadya and Arohi Snehapana


How to cite this article:
Sawarkar PG, Sawarkar GR. Comparative therapeutic response of instant and incremental oleation (Sadya and Aarohi Snehapana) over hematological and biochemical parameters in healthy volunteers: A pilot study. J Indian Sys Medicine 2019;7:151-62

How to cite this URL:
Sawarkar PG, Sawarkar GR. Comparative therapeutic response of instant and incremental oleation (Sadya and Aarohi Snehapana) over hematological and biochemical parameters in healthy volunteers: A pilot study. J Indian Sys Medicine [serial online] 2019 [cited 2020 Apr 4];7:151-62. Available from: http://www.joinsysmed.com/text.asp?2019/7/3/151/277748




  Introduction Top


Snehapana (oleation) is one of the preparatory therapies in Ayurveda, a system of medicine in India. Sneha means fat, either oil or ghee. Oleation is a prerequisite treatment in Panchakarma.[1] The ghee is made from clarified butter (obtained from cow’s milk) and it is boiled with various herbs to make a specific disease-oriented medicine of Sneha. Oleation is carried out in the morning after attending to the calls of nature, on an empty stomach for Shodhana (purification) purpose.[2] The health, age, illness condition, and digestive capacity of the patient needs to be taken into consideration when determining the dosage of Sneha for unction. The treatment lasts between minimum 3 and maximum 7 days depending on the condition of the patient and the illness being treated.[3] Many times, the oleation is used as preparative phase, which makes it an ideal suitable environment for elimination of the Dosha. But the changes that are introduced in the blood circulation due to this modality are not yet authentically established. Thereby, it is a need-based study to evaluate the hematological and biochemical changes appearing after Snehapana.

Aims and objective: The primary aim of the study was to evaluate the therapeutic response in instant and incremental oleation over hematological and biochemical changes in the body; in addition, which of the modality is effective in vogue, and the generation of collateral evidence with safety profile for the consumption of cow ghee in large amount, which is considered as unhealthy as misconception of contemporary science.


  Materials and Methods Top


Trial Design and Participants, Sample Size, Inclusion, and Exclusion

The study was randomized, parallel group, controlled trial. Between the age of 20 and 40 years, all healthy participants (both males and females) who were fit for oleation[4] were included in the study and who had aversion to the fat were excluded from the study. The study was conducted in two groups, Group A with instant oleation and Group B with incremental oleation. Total 30 participants were enrolled in the study and equally distributed in both the groups.

[INLINE 1]

With confidence interval 5% level of significance and 95% power of test using aforementioned formula.

Study Center

This study was carried out at the Mahatma Gandhi Ayurved College, Hospital and Research Centre, Salod (Hirapur), Wardha, Maharashtra, India.

Intervention

The cow ghee was the intervention drug in the study, which would be administered in two-way modality; instant and incremental. In instant oleation, cow ghee was administered at once in the quantity of 150mL stat with rock salt, whereas in incremental, it was administered in 30, 60, 90, 120, 150, 180, and 210mL dose (i.e., fixed 30mL increase daily) up to the appearance of proper oleation features for not more than 7 days.[5] Total time taken for completion of experimental study was 6 months.


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Methodology

Outcomes

The primary outcome of the study was to evaluate hematological and biochemical changes in the body in both modalities as well as which one of the modalities effective in vogue and to develop safety profile for the consumption of cow ghee in such a large amount. To assess the hematological and biochemical parameters, in Group A, the first blood sample was drawn on the very first day before starting oleation in both the groups and the second was drawn after 24h of consumption of 150mL, whereas in Group B, it was obtained after the appearance of proper oleation features as per subjective parameters quoted in context.[6]

Randomization

Block method was used to generate the random allocation sequence of the participants. Random allocation was made in blocks to keep the sizes of treatment groups similar. The randomization was carried out by allocating random permutations of treatments within each block.

Statistical Methods

Paired and unpaired t tests for mean values of normally distributed continuous data, and nonparametric tests by Wilcoxon rank sum test and Mann–Whitney rank sum test for skewed continuous variables. A P value < 0.05 was considered statistically significant. SigmaStat software for Windows, version 3.1 (Copyright 2004, SYSTAT software, USA) was used for all analyses.


  Results Top


The paired t test was used to compare hematological and biochemical parameters before and after the intervention, whereas unpaired t test was used for the comparison between Groups A and B. Where, normality test failed nonparametric Wilcoxon rank sum test for comparison within the group and Mann–Whitney rank sum test for comparison in between the groups were used for the purpose of statistic.

In [Table 1] and [Table 2], data pertaining to hematological and biochemical parameters in Group A are depicted. The findings represent that all parameters showed changes after intervention but these changes were not statistically significant except bleeding time (BT), neutrophil count, serum albumin (Sr. Alb), and serum very low-density lipoprotein (VLDL). BT and neutrophil count were found to be significantly decreased, whereas serum VLDL and Sr. Alb values were found to be significantly increased.
Table 1: Observations of hematological parameters in Group A (paired t test, instant oleation)

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Table 2: Observations of hematological parameters in Group A (Wilcoxon rank-sum test, instant oleation)

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In [Table 3] and [Table 4], data pertaining to hematological and biochemical parameters in Group B are depicted. The findings represent that all parameters showed changes after intervention but these changes were not statistically significant except serum blood urea and serum direct bilirubin, in which values significantly decreased.
Table 3: Observations of hematological parameters in Group B (paired t test, incremental oleation)

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Table 4: Observations of hematological parameters in Group B (Wilcoxon rank sum test, incremental oleation)

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In [Table 5] and [Table 6], data pertaining to hematological and biochemical parameters in Group B are depicted. The findings represent that all parameters showed changes after intervention but these changes were not statistically significant except serum protein, Sr. Alb, basophils, mean corpuscular volume (MCV), serum total bilirubin (Sr. TBil), serum glutamic-oxaloacetic transaminase (SGOT), and SGPT.
Table 5: Observations of hematological parameters in Group A (instant) and Group B (incremental) before oleation (unpaired t test)

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Table 6: Observations of hematological parameters in Group A (instant) and Group B (incremental) before oleation (Mann–Whitney rank sum test)

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In [Table 7] and [Table 8], data pertaining to hematological and biochemical parameters in Group A and Group B are depicted. The findings represent that all parameters showed changes after intervention but these changes were not statistically significant except MCV, fasting blood sugar, clotting time, basophils, Sr. TBil, serum indirect bilirubin, serum glutamic-pyruvic transaminase (SGPT), Sr. Tri, and serum VLDL.
Table 7: Observations of hematological parameters in Group A (instant) and Group B (incremental) after oleation (unpaired t test)

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Table 8: Observations of hematological parameters in Group A (instant) and Group B (incremental) after oleation (Mann–Whitney rank-sum test)

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  Discussion Top


BT in Group A reduced significantly by 14.82% because saturated fat and cholesterol–rich diet impact hemodynamic parameters, including plasma and blood viscosity, plasma triglycerides, and red blood cells deformability, which are associated with increasing the risk of circulatory disorders.[7] Fat increases blood viscosity due to a rise in hematocrit.[8] As well, Sr. Alb also increases in within range; Thalacker-Mercer et al.[9] mentioned that hepatic albumin synthesis is suppressed during an extended fasting period and is stimulated with nutrient ingestion and in Group A, bolus dose of 150mL cow ghee was highly nutrient sufficient to increase value of albumin.

Serum VLDL and LDL are well known as “bad” cholesterols because they can contribute to the formation of plaque in the arteries. But, after so much of fat consumption at once in Group A, VLDL increased by 11.76% within normal range (P < 0.05) and that was might be not increased or decreased in Group B because of incremental dose pattern as well because of confounding physiological factors.[10]

In Group B, blood urea was significantly reduced by 17.75%, this might be because of high fat administered on empty stomach early in the morning, which converts amino acids into glucose. The process of deamination removes the amino groups from amino acids and urea is formed, which is passed through the blood to the kidney for excretion from the body.[11]

Serum direct bilirubin was significantly reduced by 25% in Group B (P < 0.05). Bilirubin is the end product of heme catabolism and lipid-soluble waste product that needs to be excreted. Byoung[12] reported that a large number of healthy populations confirmed the inverse relationship between serum bilirubin level and the occurrence of nonalcoholic fatty liver disease.

While doing intergroup comparison after intervention, it was observed SGPT (Group A = 5.88% and Group B = 20%), Patell et al.[13] reported in study of non-alcoholic fatty liver disease that the mean levels of SGOT and SGPT in the two groups was found to be statistically significantly increased. So, this can happen because of intake of fat in large scale,[13] and serum VLDL (Group A = 11.76% and Group B= 22.22%) significantly increased within normal limit. VLDL particles are produced by the liver with triglyceride. They can vary depending on the quantity of triglyceride carried in the particle. When triglyceride production in the liver is increased, VLDL particles are larger in size. Whether, Sr. Tri (Group A = 2.17% and Group B = 5.38%) significantly decreased within normal range (P < 0.05). Because lipids, such as cholesterol and triglycerides, are basically insoluble in water, these must be transported in association with proteins in the circulation.[14] The reason behind this physiologic variation is not understandable and it needs more investigation and analysis.

Limitations

This study had some limitations, as larger scale study needs to be carried out to get more accurate picture of instant and incremental oleation effect on hematological and biochemical parameters. It is not clear that what type of confounding factors affecting hematological and biochemical changes in the body and responsible for physiological changes due to administration of cow ghee in large amount. On the basis of this pilot study result, further clinical trial studies need to be conducted on large sample size with controlled physiological conditions, if possible, will be required in future.

Interpretation and Conclusion

In this pilot study, it was expected to find the effect of oleation (instant and incremental) on hematological and biochemical parameters. The effectiveness of both modalities not likely to be assessed in small sample size. There were some significant results found in BT, neutrophil, Sr. Alb, and VLDL in Group A and blood urea and serum bilirubin in Group B. Whereas in both group, total bilirubin, Sr. Tri, SGPT, and VLDL, significant changes (P < 0.05) were observed within the normal limit. Though, it was concluded that both instant and incremental oleation modalities had some effect on hematological and biochemical parameters, but extension study will be needed for more practical clarification. All the changes increased or decreased in normal limit; hence, the said intervention is safe for the treatment purpose in the field of Ayurveda. This study aimed to develop and evaluate the feasibility and acceptability of treatment method of Ayurveda.

Ethical clearance

Ethical clearance for this study was obtained (Ref. no. DMIMS (DU)/IEC/2017–18/6357).

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

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Sharma P. Sutrasthana, Chapter 13/61. In: Charaka Samhita. English Translation. Volume I. Reprint ed. Varanasi, India: Chaukhambha Orientalia; 2007. p. 91.  Back to cited text no. 1
    
2.
Yadavji T. Chikitsasthana, Chapter 31/74. In: Sushruta Samhita. Nibandhasangraha. Commentary. Volume II. 9th ed. Varanasi, India: Chaukhambha Orientalia; 2007. p. 510.  Back to cited text no. 2
    
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Sharma PS. Chapter 1/6. In: Charaka Samhita. English Translation. Volume II. 8th ed. Varanasi, India: Chaukhambha Orientalia; 2007. p. 510.  Back to cited text no. 3
    
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Sharma P. Sutrasthana, Chapter 13/52. In: Charaka Samhita. English Translation. Volume I. Reprint ed. Varansi, India: Chaukhambha Orientalia; 2007. p. 90.  Back to cited text no. 4
    
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Sharma P. Siddhistahna, Chapter 1/6. In: Charaka Samhita. English Translation. Volume II. 8th ed. Varanasi, India: Chaukhambha Orientalia; 2007. p. 587.  Back to cited text no. 5
    
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Yadavji T. Chikitsasthana, Chapter 31/33. In: Sushruta Samhita. Volume II. Varanasi, India: Chaukhamba Surbharati Prakashan; 2013. p. 511.  Back to cited text no. 6
    
7.
Cicha I, Suzuki Y, Tateishi N, Maeda N. Effects of dietary triglycerides on rheological properties of human red blood cells (abstract). Clin Hemorheol Microcirc 2004;30:301-5.  Back to cited text no. 7
    
8.
Guiraudou M, Varlet-Marie E, Raynaud de Mauverger E, Brun JF, Obesity-related increase in whole blood viscosity includes different profiles according to fat localization. Clin Hemorheol Microcirc 2013;55:63-73.  Back to cited text no. 8
    
9.
Thalacker-Mercer AE, Johnson CA, Yarasheski KE, Carnell NS, Campbell WW. Nutrient ingestion, protein intake, and sex, but not age, affect the albumin synthesis rate in humans. J Nutr 2007;137:1734-40.  Back to cited text no. 9
    
10.
DiNicolantonio JJ, O’Keefe JH. Effects of dietary fats on blood lipids: A review of direct comparison trials. Open Heart 2018;5:e000871.  Back to cited text no. 10
    
11.
The Digestive System. Available from: https://www2.estrellamountain.edu/faculty/farabee/biobk/BioBookDIGEST.html.  Back to cited text no. 11
    
12.
Byoung Kuk J. Elevated serum bilirubin levels are inversely associated with nonalcoholic fatty liver disease. Clin Mol Hepatol 2012;18:357-9.  Back to cited text no. 12
    
13.
Patell R, Dosi R, Joshi H, Sheth S, Shah P, Jasdanwala S. Non-alcoholic fatty liver disease (NAFLD) in obesity. J Clin Diagn Res 2014;8:62-6.  Back to cited text no. 13
    
14.
Kenneth RF, Carl G. Introduction to lipids and lipoproteins. Book Shelf 2018. Bookshelf ID: NBK305896, PMID: 26247089. Available from: https://www.ncbi.nlm.nih.gov/books/NBK305896/.  Back to cited text no. 14
    



 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7], [Table 8], [Table 9]



 

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